Tests an ultrasound catheter treatment for high blood pressure
Tests an ultrasound catheter procedure in adults with essential hypertension.
Plain-language title generated from the registry record
Registry title: To Evaluate the Safety and Efficacy of a Single-Use IVUS Ablation for Primary Hypertension
Key facts
- Where
- Beijing, Chengdu, Chongqing, Hangzhou, Hohhot, Jinan, Lanzhou, Shanghai, Shenzhen, Xi’an, Xiamen, Xining, Yinchuan, and Zhengzhou, ChinaSee the 18 sites
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 75 years old?
Source: NCT07051811, who can take part
Where in China
- Beijing Anzhen Hospital, Capital Medical UniversityBeijing, ChinaTaking people
- Beijing Jishuitan Hospital affiliated to Capital Medical UniversityBeijing, ChinaTaking people
- Beijing Tsinghua Changgung HospitalBeijing, ChinaTaking people
- China-Japan Friendship HospitalBeijing, ChinaTaking people
- Peking University First HospitalBeijing, ChinaNot yet recruiting
- West China Hospital，Sichuan UniversityChengdu, ChinaTaking people
- The Second Affiliated Hospital Chongqing Medical UniversityChongqing, ChinaTaking people
- Zhejiang HospitalHangzhou, ChinaTaking people
- Inner Mongolia People's HospitalHohhot, ChinaTaking people
- Qilu Hospital of Shandong UniversityJinan, ChinaTaking people
- The Second Hospital of Lanzhou UniversityLanzhou, ChinaTaking people
- Shanghai East HospitalShanghai, ChinaTaking people
- Shenzhen university General HospitalShenzhen, ChinaNot yet recruiting
- The First Affiliated Hospital of Xi'an Jiaotong UniversityXi’an, ChinaTaking people
- The First Affiliated hospital of Xiamen UniversityXiamen, ChinaNot yet recruiting
- Affiliated Hospital of Qinghai UniversityXining, ChinaTaking people
- Yinchuan First People's HospitalYinchuan, ChinaTaking people
- Henan Provincial People's HospitalZhengzhou, ChinaTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Lepu Medical Technology (Beijing) Co., Ltd.
- Trial code
- NCT07051811
- Record updated
- 4 July 2025
- Original description
This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.Read full original descriptionShow less
A Prospective, Multicenter, Blinded, Randomized Controlled Clinical Trial Evaluating the Safety and Efficacy of a Single-Use Intravascular Ultrasound Ablation Catheter and Ultrasound Ablation System in the Treatment of Primary Hypertension
This is a prospective, multicenter, blinded, randomized controlled clinical trial designed to evaluate the safety and efficacy of a single-use intravascular ultrasound ablation catheter and ultrasound ablation system in the treatment of primary hypertension.
Inclusion: Aged ≥18 years and ≤75 years, regardless of gender; Documented history of primary hypertension; Stable use of at least two antihypertensive medications for a minimum of 4 consecutive weeks prior to randomization, specifically requiring a combination of an angiotensin II receptor blocker (ARB) and a calcium channel blocker (CCB) or a triple combination of ARB/CCB plus a diuretic agent . After at least 4 consecutive weeks of screening, blood pressure must meet the following criteria:; Office systolic blood pressure (SBP) ≥150 mmHg and <180 mmHg; Office diastolic blood pressure (DBP) ≥90 mmHg; 24-hour ambulatory systolic blood pressure ≥135 mmHg and <170 mmHg; Patients who can understand the purpose of the trial, voluntarily participate and sign the informed consent form, and are willing to comply with clinical follow-up.
Exclusion: Recent Vascular Events:Acute myocardial infarction, unstable angina, syncope, or cerebrovascular accident within 3 months prior to signing the informed consent form; Prior Renal Artery Denervation Procedure; Diagnosis of Type 1 Diabetes Mellitus; Suspected Secondary Hypertension; Allergy to Contrast Agents; Estimated Glomerular Filtration Rate (eGFR) <45 mL/min/1.73 m²; Unsuitable Renal Artery Anatomy for Treatment; Main renal artery diameter <4 mm or length <20 mm; Accessory renal artery diameter ≥ 2 mm and <4 mm; Renal artery stenosis >50% in the main renal artery; Renal artery aneurysm, fibromuscular dysplasia, or severe calcification; Presence of a renal artery stent; Single kidney; Orthostatic Hypotension; Respiratory Support:a) Requirement for long-term oxygen support or mechanical ventilation (excluding nocturnal respiratory support for sleep apnea); Life Expectancy <1 Year; Pregnancy, Lactation, or Plans to Become Pregnant Within 6 Months (for Females); Males Planning to Conceive Within 6 Months; Current Participation in Another Clinical Trial Without Completion of the Primary Endpoint; Other Reasons Deemed by the Investigator to Make the Subject Unsuitable for Participation (e.g., Poor Compliance).